Senate Introduces Bill to Change OTC Monograph System
In August 2017, PDG published a paper entitled FDA OTC Monograph Changes Coming: User Fees, Pre-submission Meetings and Electronic Submissions. Although not included in the Food and Drug Administration Reauthorization Act (FDARA: included among others PDUFA VI/GDUFA II), the changes have emerged in Senate Bill 2315, introduced on January 17, 2018. CHPA reported “Today, the…